Leronlimab (350 mg) Weekly Use for 14 Weeks in Open Label Arm of NASH Trial Produces Fibrosis Reduction as High as 93 msec Amongst First 15 Patients with Average Reduction of 24 msec

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today reported data from its trial treating NASH (nonalcoholic steatohepatitis) open label with leronlimab.

Leronlimab open label NASH results continue to show reductions in fat and fibrosis suggestive of a potential therapy not only for NAFLD (Non-Alcoholic Fatty Liver Deposit) but also in NASH. Fat reductions by proton density fat fraction PDFF up to 45% along with reductions in fibrosis up to 8% by CT1 were noted from baseline after just 14 weeks of treatment. The reductions in fibrosis were seen in both severe and mild-moderate NASH cases.

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, stated, “Though numerous drugs have been evaluated in clinical trials, there have been no approvals by the U.S. Food and Drug Administration for treating biopsy-proven NASH. We are encouraged by the continued results and look forward to presenting the full trial results after database lock. We believe this reported data is an exciting step forward in research and demonstrates the potential of leronlimab for inhibiting the liver fibrosis associated with NASH. CytoDyn will now file for Fast Track Designation for both the indications of NASH and NAFLD. Once the full results are reported, which we anticipate to be available in mid-December, we may proceed to file a Phase 3 protocol with the FDA and request accelerated approval.”

About CytoDyn

CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 plays a critical role in the ability of HIV to enter and infect healthy T-cells and appears to be implicated in tumor metastasis and immune-mediated illnesses, such as NASH.

CytoDyn successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected patients who were heavily treatment-experienced individuals with limited treatment options. CytoDyn is working diligently to resubmit its BLA for this HIV combination therapy since receiving a Refusal to File in July 2020. In July 2021, CytoDyn announced that it had submitted a dose justification report to the FDA, an integral step in the resubmission process for its BLA, which it expects to complete by the end of the first quarter of calendar 2022. CytoDyn also completed a Phase 2b/3 investigative trial with leronlimab used as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label expansion approval. Clinical results to date from two trials have shown that leronlimab can maintain a suppressed viral load in a sub-population of R5 HIV patients who chose to switch from their daily pills regimen to once-a-week subcutaneous dose of leronlimab. Several patients on leronlimab’s Phase 2b extension arm have remained virally suppressed for almost 7 years and many patients in our Phase 2b/3 investigative trial are passing two and some four years of monotherapy with suppressed viral load.